Compilation of the Social Security Laws

REPORTING OF INFORMATION RELATING TO DRUG SAMPLES

Sec. 1128H. [42 U.S.C. 1320a-7i](a) In General.—Not later than April 1 of each year (beginning with 2012), each
manufacturer and authorized distributor of record of an applicable
drug shall submit to the Secretary (in a form and manner specified
by the Secretary) the following information with respect to the preceding
year:

(1) In the case of
a manufacturer or authorized distributor of record which makes distributions
by mail or common carrier under subsection (d)(2) of section 503 of
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 353), the identity
and quantity of drug samples requested and the identity and quantity
of drug samples distributed under such subsection during that year,
aggregated by—

(A) the name,
address, professional designation, and signature of the practitioner
making the request under subparagraph (A)(i) of such subsection, or
of any individual who makes or signs for the request on behalf of
the practitioner; and

(B) any other
category of information determined appropriate by the Secretary.

(2) In the case of
a manufacturer or authorized distributor of record which makes distributions
by means other than mail or common carrier under subsection (d)(3)
of such section 503, the identity and quantity of drug samples requested
and the identity and quantity of drug samples distributed under such
subsection during that year, aggregated by—

(A) the name,
address, professional designation, and signature of the practitioner
making the request under subparagraph (A)(i) of such subsection, or
of any individual who makes or signs for the request on behalf of
the practitioner; and

(B) any other
category of information determined appropriate by the Secretary.

Follow:

External Link Disclaimer

You are exiting the Social Security Administration's website.

SSA cannot attest to the accuracy of information provided by such websites. If we provide a link to such a website, this does not constitute an endorsement by SSA or any of its employees of the information or products presented on the non-SSA website.

Also, such websites are not within our control and may not follow the same privacy, security or accessibility policies. Once you visit such a website you are subject to the policies of that site.